Johnson & Johnson’s Darzalex made multiple myeloma history this May when it became the first monoclonal antibody to score an FDA approval in newly diagnosed patients. And now, it’s looking to make it a repeat.

Tuesday at the American Society of Hematology annual meeting, J&J rolled out data that could change the equation for previously untreated patients who aren't eligible for stem cell transplant. Darzalex, in combination with the standard-of-care regimen of Celgene’s Revlimid and dexamethasone (Rd), cut the risk of disease progression or death by 44% compared with the Rd combo alone.

Those results had Mark Wildgust, VP of global medical affairs for oncology at J&J’s Janssen unit, predicting the trio would become the "new standard of care."

At a median follow-up of 28 months, "we’re nowhere near" the median progression-free survival for the Darzalex regimen, he said. In the phase 3 study, dubbed Maia, Revlimid and dexamethasone recorded median progression-free survival of 31.9 months. Darzalex also helped drive up complete response rates to 48% versus 25% for Rd.

Together, the data "really represents a practice-changing moment," Wildgust said. "For those patients today whom hematologists would think about giving Rev-dex, you should really be using" Darzalex alongside the combo. "It’s very convincing," he added.

As of May, Darzalex already has an approval in newly diagnosed, transplant-ineligible myeloma patients, but that nod covers its use with Takeda’s Velcade and prednisone. And as Wildgust pointed out, "there are patients out there today that you really can’t give Velcade."

The new Maia data is "really for those elderly patients who really can’t tolerate" Velcade, he said. And now, with two batches of positive data in this patient population under its belt, J&J thinks it has the pool pretty well covered.

"Both of them together really give you the evidence—you really should be adding (Darzalex) to the standard of care for those transplant ineligible patients," Wildgust said.

Since winning its first approval in late 2015, the drug has made quick work of moving into earlier lines of therapy to expand its use. In the third quarter, Darzalex brought in $498 million in worldwide sales, and it’s already cracked the blockbuster barrier with $1.44 billion through the first three quarters of 2018.

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